Kornimate/medical-research-clean huggingface dataset:
the effects of manual lymphatic drainage and transcutaneous electrical nerve stimulation in premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: the aim of this study is to (a) investigate the effects of manual lymphatic drainage and transcutaneous electrical nerve stimulation on the severity of syndrome symptoms, pain, heart rate variability, and quality of life in women with premenstrual syndrome, and (b) compare the effectiveness of these two methods. female participants who met the inclusion criteria and volunteered to participate in the study will be called approximately one week before menstruation. after the participants are randomly divided into 3 groups, their baseline assessments will be made. then, the participants will be treated according to the group they are assigned to. treatments will be applied for 5 days and once a day. no treatment will be applied to the control group. the assessments will be repeated after the treatment, on 1st day of menstruation, two days before the next menstruation, and on the first day of the next menstruation. the hypothesis of this study is that manual lymphatic drainage and transcutaneous electrical nerve stimulation have positive effects on the severity of premenstrual syndrome symptoms, pain, heart rate variability, and quality of life.


Eligibility criteria:
inclusion criteria: * women aged between18-45 years-old * regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days) * premenstrual syndrome (according to the premenstrual syndrome scale, be above 110 points) exclusion criteria: * pregnancy * premenstrual dysphoric disorder * menopause * chronic disease * continuous use of medication * under hormonal therapy * infection * using any method to cope with premenstrual syndrome

Keywords: manual lymphatic drainage transcutaneous electrical nerve stimulation premenstrual syndrome quality of life autonomic functions
evaluation of non-pharmacological and pharmacological treatment for overweight and obesity in patients of the outpatient register (eva)

Conditions: Overweight and Obesity

Summary: a prospective non-interventional single-centre study aimed to assess the current practice of non-pharmacological treatment and pharmacological therapy of overweight and obesity in patients with cardiovascular diseases (cvd) or with a high risk of cvd according to the patients' survey data

to interview 300 patients with a body mass index (bmi) ≥25 kg / m² of the outpatient register, who come for a primary or secondary visit to the center. the specifically designed questionnaire contains topics about patients' self-concept of their body mass; doctors' prescriptions of therapy for obesity, patients' adherence to recommendations. a repeated short telephone interview of these patients will be conducted in 1-1.5 years after visit inclusion to clarify the dynamics of weight and methods of its correction.

Eligibility criteria:
inclusion criteria: patients of the outpatient "profile" registry with cvd or with a high risk of cvd (≥5%), with overweight (bmi≥25 kg/m2) or obesity (bmi≥30 kg/m2). presence of written informed consent to participate in the study, fill in the original questionnaire and given consent to the processing of personal data exclusion criteria: normal weight, pregnancy

Keywords: overweight,obesity,patients' survey,drug&non-drug treatment
take away food allergy; inducing tolerance in children allergic to peanut

Conditions: Food Hypersensitivity

Summary: the purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut.

the study is an open randomized controlled study on oral immunotherapy including 60 children (40 on active treatment, 20 controls) with primary peanut allergy. the study has 4 phases: 1: inclusion/randomization including a double blind placebo controlled food challenge 2: bi weekly up-dosing to maintenance dose after 48 weeks, 3: maintenance period of 3 years 4: 1 year follow up after end of treatment. clinical parameters as well as immunological (serological and cellular) will be recorded at inclusion, after 3 months of up-dosing, at end of up-dosing, after 1 and 3 years of maintenance treatment and after 3 and 12 year of follow up.

Eligibility criteria:
inclusion criteria: * positive skin prick test or ige to peanut * age 5-15 yrs * primary peanut allergy verified by objective symptoms to dbpcfc by a dose of 3 mg or more peanut potein exclusion criteria: * non controlled asthma (by asthma control test, act) * allergy/intolerance to any other ingredients in the vehicle used for the peanut dbpcfc * current or previous allergen specific immunotherapy * cardiac disease with increased risk of serious anaphylaxis * severe atopic skin disease * diabetes mellitus * severe disease that interferes with adherence to study protocol

Keywords: peanut allergy oral immunotherapy
effect of good pain management (gpm) ward program on moderate to severe cancer pain patients

Conditions: Cancer; Pain

Summary: this study aims to set up a standardized cancer pain ward - known as the good pain management (gpm) ward with streamlined assessment and management procedures to act as a pain management model. in particular, it will enforce regular pain assessment from and throughout hospital admission, and treatment protocols introducing the use of strong-opioids in moderate cancer pain patients, following national cancer care network (nccn) adult cancer pain guidelines. the gpm ward will be compared against current-practice controlled ward.

this is a double-arm, randomized, multi-center, current practice-controlled study. approximately 150 cancer pain patients with collecting questionnaires admitted to an inpatient department from 3 national hospitals: kaohsiung medical university hospital, kaohsiung municipal ta-tung hospital and kaohsiung municipal hsiaokang hospital will be invited into this study. eligible patients will be randomized to one of the following pain control wards in a 1:1 ratio. * gpm ward: good pain management ward * control ward: current practice-controlled ward surveys, pain level measurements and dosage used will be collected in 48±8 hours. the pain management index (pmi) will be assessed as primary objective. the patient satisfaction, outcome questionnaire (aps-poq) and sf-36 will be assessed in secondary objectives. once patient is admitted to the ward and agrees to participate in the study, the patient will be randomly and blindly assigned to either gpm ward or control ward. in the control ward, patient will receive the current practice of pain management, with less assessment procedure. this study will investigate the benefits and effect of good pain control on patient outcomes in hospitalized cancer pain patients. the results aim to demonstrate the viability of gpm ward in daily practices and its measurable impact on the patient outcomes including patient treatment satisfaction as well as quality of life. 1. primary objectives: • to assess pain management index (pmi) 2. secondary objectives: (1) to assess the satisfaction of pain control during admission (2) to analyze the patient outcome questionnaire (aps-poq) (3) to analyze the sf-36 questionnaire

Eligibility criteria:
inclusion criteria: 1. females and males aged ≥ 20 2. understand chinese/taiwanese and able to finish the questionnaire 3. alert enough to respond and understand 4. hospitalized for ≥ 24 hours 5. ecog ≤ 2 6. cancer patients with cancer-related pain exclusion criteria: 1. patient diagnosed with non-cancer pain or unexplained pain 2. patient with moderate to severe mental disorder 3. patient receiving operation or invasive procedure within 24 hours before admission

Keywords: cancer pain gpm pain assessment
development of the partial pressure of carbon dioxide during exercise and at night in patients with chronic obstructive pulmonary disease (copd) iv

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to investigate the development of partial pressure of carbon dioxide during the 6-min walking test and during night in chronic obstructive pulmonary disease (copd)-patients (gold stage iv). therefore the partial pressure of carbon dioxide, oxygen saturation and the heart rate are registered by a device called "sentec" during the mentioned periods. in addition a measurement of activity is realised by an activity monitor ("sensewear").


Eligibility criteria:
inclusion criteria: * copd iv with and without a respiratory insufficiency * maximal paco² of 55mmhg at admission (taken at rest by blood gas analysis without ltot) exclusion criteria: * paco² \> 55mmhg * non-invasive ventilation * acute exacerbation

Keywords: copd carbon dioxide 6-minute walking test
vitamin b12a vasoplegic syndrome

Conditions: Vasoplegic Syndrome

Summary: the study team will evaluate the medication hydroxocobalamin (b12a) for treatment of low blood pressure after cardiac surgery.

if subjects meet the criteria for inclusion in the study based on the subjects blood pressure the subject will be randomized to receive the study drug or a placebo. subjects blood pressure will be monitored closely for the first 30 minutes and then have standard intensive care unit (icu) care afterwards. kidney dysfunction will be assessed for changes in urine production and laboratory values that are followed as a part of standard postoperative care. study coordinators will obtain these values from subjects medical records for 7 days and subjects will be contacted by phone for follow up after 30 days.

Eligibility criteria:
inclusion criteria: * any patient for whom we are able to obtain consent ahead of their procedure * patients presenting for a procedure in which cardiopulmonary bypass will be required * considered high risk for vasoplegic syndrome * has no contraindications to arterial line or pa catheter placement * develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary bypass. exclusion criteria: * age\<18 years * known pregnancy or patients without a documented pregnancy test if not menopausal. * known prior anaphylactic or allergic reaction to b12a * ckd stage 4 or worse * ecmo (extracorporeal membrane oxygenation) prior to study consent. * patients currently on cardiopulmonary bypass

Keywords: vitamin b12a hypotension cardiopulmonary bypass
safety and effectiveness of azli (an inhaled antibiotic) in adults with non-cystic fibrosis bronchiectasis

Conditions: Bronchiectasis

Summary: the air-bx2 study enrolled people with non-cystic fibrosis (non-cf) bronchiectasis and gram-negative airway infection. participants received two 28-day courses of either aztreonam for inhalation solution (azli) or placebo taken 3 times a day. each course was followed by a 28-day off-drug period. following the two blinded courses, all participants received a 28-day course of open-label azli then were followed for an additional 56 days.


Eligibility criteria:
inclusion criteria: * male/female 18 years or older with non-cf bronchiectasis * chronic sputum production on most days * positive sputum culture for gram-negative organisms * must have met lung function requirements exclusion criteria: * history of cf * hospitalized within 14 days prior to joining the study * previous exposure to azli * pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study * must have met liver and kidney function requirements * continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed) * treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment * other serious medical conditions.
zalutumumab with or without irinotecan chemotherapy in cetuximab-refractory colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this trial is to determine the safety and efficacy of zalutumumab alone or in combination with irinotecan for the treatment of patients with colorectal cancer


Eligibility criteria:
inclusion criteria: 1. males and females age ≥ 18 years 2. confirmed diagnosis of crc 3. documented disease progression 4. failure and/or intolerance to standard chemotherapy exclusion criteria: 1. prior treatment with anti-egfr antibodies other than cetuximab 2. expected survival \< 3 months 3. clinical significant cardiac disease and/or uncontrolled medical conditions

Keywords: colorectal neoplasms colorectal tumors colorectal carcinoma
utilization of simulated grid (simgrid™) technology for the reduction of ionizing radiation dose on x-ray examination in obese patients

Conditions: Obesity, Morbid

Summary: the purpose of this research study is to learn if a new imaging processing technique called simulated grid (simgrid™) will help in getting better quality x-ray images in obese subjects. the gm85 digital radiography machine will be used to obtain x-ray images.


Eligibility criteria:
inclusion criteria: * obese adult volunteers with body-mass index (bmi) exceeding 30 * subjects that require at least one x-ray for continuation of care exclusion criteria: * subject who is known to have lung disease(s) which would interfere with the interpretation of the chest radiography image * subject who is pregnant or breastfeeding
autosomal dominant retinitis pigmentosa: prevalence of known genes identification of new loci / genes

Conditions: Autosomal Dominant Retinitis Pigmentosa

Summary: identify new genes responsible for autosomal dominant retinitis pigmentosa (adrp), one of the most common causes of hereditary diseases of the retina, and thus better understand the mechanisms involved of the disease."

two hundred and fifty samples from unrelated patients, from which 150 were provided by the national reference center of rare disease in montpellier and 100 recruited in the 9 participating centers over a period of two years."to identify the missing genes, we proceed in two steps. a first step in selecting families negative for the 8 major genes genes, by systematic sequencing of exons most frequently involved. a second step in finding new loci / genes by locus exclusion using microsatellite markers and snp genotyping.

Eligibility criteria:
inclusion criteria: * retinitis pigmentosa diagnosed * autosomal dominant transmission diagnosed * aged from 5 to 80 years * informed consent * affiliated or benefit from an insurance regimen exclusion criteria: -

Keywords: autosomal dominant retinitis pigmentosa rare disease genetics
phacoemulsification vs slt as initial treatment for pseudoexfoliation glaucoma

Conditions: Pseudoexfoliation Glaucoma

Summary: the canadian pseudoexfoliation glaucoma study 1 is a randomized clinical trial that aims to compare two initial treatment options - selective laser trabeculoplasty (slt) and phacoemulsification (phaco) - in newly diagnosed patients with pseudoexfoliation and need to lower the intraocular pressure. patients with pseudoexfoliation and a recent decision to lower the intraocular pressure, who also have early asymptomatic lens opacification will be recruited and randomized to receive either slt or phaco. patients will be followed for 2 years according to a target iop protocol based on the canadian ophthalmological society glaucoma guidelines. patients who do not achieve the target iop with the initial randomization procedure will receive iop lowering medications. the main outcome of interest will be the proportion of subjects who need iop lowering medications after 2 years. secondary outcomes include iop reduction, time to need medications, patient reported outcomes in terms of visual function, and occurrence of adverse effects. to obtain longer follow-up information beyond two years, a chart review will be done 5 and 10 years after randomization.


Eligibility criteria:
inclusion criteria: 1. pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material on anterior capsule, pupil, or anterior chamber angle 2. clinical decision to lower the iop, as assessed by the investigator who is treating the subject, based on the presence of pxg or with iop elevated enough to warrant treatment, even without clear evidence of optic nerve damage or visual field defect 3. presence of asymptomatic early cataract exclusion criteria: 1. age less than 50 years old 2. anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum visible in less than 180º 3. previous iop lowering procedure such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery 4. previous use of iop lowering medication for more than 6 months 5. presence of ocular or systemic pathology or medication that could significantly influence the iop, such as: uveitis, neovascular or traumatic glaucoma, corneal pathology influencing tonometry, use of oral steroids 6. iop at baseline visit higher than 36 mmhg 7. visual field damage at baseline visit with mean deviation worse than -15 db 8. not able or willing to provide voluntary, informed consent to participate in the study
ati-450 vs placebo in patients with moderate to severe hidradenitis suppurativa (hs)

Conditions: Hidradenitis Suppurativa

Summary: this is a phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ati-450 vs placebo in patients with moderate to severe hidradenitis suppurativa (hs).

this is a phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ati-450 vs placebo in patients with moderate to severe hidradenitis suppurativa (hs).

Eligibility criteria:
inclusion criteria: * able to comprehend and be willing to sign the institutional review board (irb)-approved patient informed consent form prior to administration of any study-related procedures. * patient must have stable hs. * total abscesses and/or nodule (an) count of ≥5 at baseline visit. * hs lesions present in at least 2 distinct anatomical areas at screening and baseline. exclusion criteria: * patient has a history of active skin disease other than hs that could interfere with the assessment of hs. * patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism. * patient has experience with \>2 biologics, \>1 janus kinase (jak) inhibitor, or a combination of 1 biologic experience and 1 jak inhibitor. * are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit.

Keywords: hidradenitis suppurativa hs acne inversa
evaluation of lower extremity athletic injuries and response to treatment using swe and mfi

Conditions: Lower Extremity Musculoskeletal Injury

Summary: primary objective: to explore changes in shear wave elastography (swe) and microvascular flow imaging (mfi) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment. secondary objective: to develop a deep learning ai system for automated region of interest (roi) determination for measurement of average swe and mfi. methodology: eligible subjects with lower extremity injuries will undergo swe and mfi measurements and complete the lower extremity functional scale questionnaire at each study visit. clinical data related to the evaluation of the injury acquired during standard medical care of the injury will be collected from the patients' medical record such as ct or mri scans, x-rays, physical exams and tests as well as laboratory measurements. subjects will undergo serial swe and mfi imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.


Eligibility criteria:
inclusion criteria: * subjects age 18 - 89 years; * able to sign an informed consent document; * suspected msk injury of the lower extremity (i.e. hamstring injuries and soft tissue injuries involving the ankle). exclusion criteria: * prior fasciotomy of same limb; * hemodialysis grafts of involved extremity; * extremity wounds preventing ultrasound imaging.

Keywords: ultrasound shear wave elastography microvascular flow imaging
a study to assess the reliability/feasibility of using emerald touchless sensor for scratching and sleep quantification in a subset of participants from pedistad study (obs15333; nct03687359)

Conditions: Dermatitis Atopic

Summary: primary objective: to explore and quantify the association between nighttime scratching and sleep patterns objectively in pediatric participants with moderate to severe atopic dermatitis (ad) using an innovative emerald touchless sensor. secondary objective: to evaluate the feasibility of using the emerald touchless sensor in a pediatric clinical trial setting.

16 weeks

Eligibility criteria:
inclusion criteria: * participation in obs15333 pediatric ad registry (pedistad) in the united states (us) study sites. * enrolled in pedistad, age more than or equal to 6 years to less than 12 years at the time of enrollment. * peak pruritus numeric rating scale (nrs) last night more than or equal to 4 at screening. * participant must have home access to reliable and operational wi-fi and broadband internet at screening and throughout the study period. * participants/parents must have a device (mobile phone, tablet or computer) to record daily itch and sleep disturbance at screening and throughout the study period. * participant agrees to sleep by himself/herself (ie, with no other individuals or pets) in the monitored bedroom for the duration of the study (if not all times, at least 5 days a week for a minimum of 5 hours/night for a total of 16 weeks). * signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age. exclusion criteria: - known history of a childhood sleep disorder such as parasomnias (sleep walking, talking, terrors, etc.), behavioral insomnia of childhood, or restless leg syndrome. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
effect of patient education related to cv risk factors in type 2 diabetes mellitus(patrol).

Conditions: Glycemia; Hypertension; Hyperlipidemia

Summary: this study will address the proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ada 2008 guideline, among outpatients coming to the korean primary care nationwide.


Eligibility criteria:
inclusion criteria: * patients who had been diagnosed with type ii diabetes mellitus * patients with hypertension and / or hyperlipidemia * patients who had agreed to informed exclusion criteria: * patients who had been diagnosed with type i diabetes mellitus * patients with neither hypertension and hyperlipidemia

Keywords: hypertension type ii dm hyperlipidemia glycemia ada 2008 guideline patient consultation